Drug Approval Package: Procysbi
Company: Horizon Pharma USA, Inc.
Application Number: 213491
Approval Date: 02/14/2020
Application Number: 213491
Approval Date: 02/14/2020
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FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Chemistry Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
Date created: May 29, 2019
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